Eli Lilly announced Wednesday that the FDA has delayed approval of a long acting version of its schizophrenia drug olanzapine pending a proposal for a Risk Evaluation and Mitigation Strategy (REMS). The company says it will submit the proposal in the "near future," but did not offer a time period. "We cannot speculate on the timing of a potential decision, but remain confident that, if approved, the long-acting depot formulation of olanzapine will offer an important option for treating this devastating and chronic illness," said Todd Durell, M.D., associate medical director for U.S. neuroscience for Lilly.
Olanzapine--an atypical antipsychotic--is Lilly's top selling drug. The antipsychotic is currently marketed in the US as Zyprexa, a once-daily treatment for symptoms of schizophrenia and bipolar disorder. The long acting version would be administered via injection once every four weeks.
The good news for Lilly? The company received a complete response letter rather than a flat rejection as it has in the past. The FDA responded to Lilly's app with a not-approvable letter in February of 2008, despite a recommendation from the advisory panel and again sent Lilly back to the drawing board in May, after another panel's review of the trial data raised questions regarding excessive sedation among patients.
- read Lilly's release
- more on the Zyprexa controversy